CNS Changes Following SCI

Recruiting

• Conditions: Spinal Cord Injuries
• Interventions: Diagnostic Test: MRI

• Registration Number: NCT03772548
• Lead Sponsor: University of Zurich

Brief Summary

The objective of this study is to better understand the structural and functional changes that the central nervous system (CNS) undergoes following spinal cord injury and how these changes relate to clinical measures. Both macroscopic and microscopic changes of the brain and the spinal cord will be examined in SCI patients and compared to healthy controls. In terms of structural plasticity, we aim to identify MR biomarkers that allow predicting the course of the patient's neurological status and accurately describe the course of the disease and the recovery. Importantly, we aim to investigate which factors scale the patients' symptoms. In terms of functional plasticity, we will combine fMRI with behavioural testing to understand which clinical and behavioural determinants drive functional hand representations in the primary somatosensory and motor cortices to be maintained and which determinants drive reorganisation of functional representations following sensory input loss. We will further investigate the contribution of brainstem reorganisation to plasticity observed at the cortical level and, by doing so, aim to better understand the mechanistic underpinnings of functional reorganisation.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-18
• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-12-10
• Study First Posted: 2018-12-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-25
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with spinal cord injury	MRI	-
Healthy subjects	MRI	-

Primary Outcome Measures

Name	Time	Method
Conventional magnetic resonance imaging (MRI) parameter	Up to 50 weeks	Structural characteristics in the brain and cervical spinal cord are assessed in acute to chronic spinal cord injury (SCI) patients using conventional MRI and compared to healthy controls

Secondary Outcome Measures

Name	Time	Method
Magnetic resonance spectroscopy (MRS) parameter	Up to 50 weeks	Metabolic parameters are assessed in acute to chronic SCI patients using MRS in the brain and cervical spinal cord and compared to healthy controls
Change of functional MRI (fMRI) parameter between 2 to 4 time points	Up to 50 weeks	Change of brain activities is assessed between 2 to 4 time points using fMRI during resting-state or a specific task in acute to chronic SCI patients and compared to healthy controls

Trial Locations

Locations (1)

Universitätsklinik Balgrist; 🇨🇭 Zürich, Switzerland